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e.tract - structured workspaces and electronic Trial Master File

e.tract logo e.tract is a a web-based online platform for secure collaboration of all partners in clinical trials. The software simplifies editing, sharing, tracking and archiving of study documents. Central domains of this platform are individually structured workspaces and an electronic Trial Master File (eTMF) that is adapted to the DIA Reference Model.

Based on the technical features of the collaboration platform BSCW and from the experiences of the eTMF working group of the DIA, the current version 2.0 of the TMF reference model was adapted in BSCW. Substantive explanations of the various sections allow an easy navigation for non-professionals. The search is further facilitated using keywords and descriptions. Therefore the tracking of the status and the storage position of a document is very easy to allocate. Due to the given structure reliability is achieved in the maintenance of documents and completeness of the TMF.

e.tract in a nutshell

  • e.tract allows CROs, institutions, pharmaceutical and biotech companies to streamline their processes and to exchange information more effectively.
  • e.tract supports sponsor, investigational sites, monitor/SM and other stakeholders in an ongoing clinical trial.
  • e.tract is useful for biotechs in the early development of their substances and as part of a "due diligence".
  • e.tract helps small and medium CROs and academic institutions to remain competitive.
  • e.tract ensures that the responsible investigational study team, as well as the supervising monitor is always up-to-date in a timely manner.
  • e.tract is an important assistant in upcoming emergency audit preparations and inspections.

Key Features

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  • standardization of documents and processes.
  • availability of all documents with controlled access rights and audit trail.
  • simple set up of a new study.
  • "one click" archives of selected parts or the complete TMF.
  • increase transparency and traceability, while time and cost saving: enables international cooperation, simple set up of study and tracking of documents.
  • ease of implementation within existing structures, cost effective variant by providing a secure cloud (no separate server architecture necessary or additional internal IT costs).

Availability

The e.tract platform is offered as a cloud service by OrbiTeam Software GmbH & Co. KG. e.tract users access the online system with a web browser over a secure connection by means of a user ID and password. OrbiTeam assumes responsibility for installing the software for the entire service, including data backup and support. That allows you to fully concentrate on managing your clinical trial. Qualitative personal support like the "Doc-Keepers", which may temporarily or permanently be booked, provides additional safety.

More Information

Visit the e.tract homepage to learn more about features, functionality and pricing models or to get a free online demonstration account to the system. e.tract is a product by SACURA GmbH, the clinical research experts, and OrbiTeam Software GmbH & Co. KG a spin-off of the Fraunhofer FIT and developer and distributor of the web-based collaboration platform BSCW. Both companies intend to support small and mid-sized biotechs and CROs with a favourable price for this eTMF and document management platform.

Have we piqued your interest? Do you need further details or do you have specific questions?
We would be glad to help! If you have any questions regarding the e.tract platform, please contact us!